Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Polidocanol

Sclerosing Solutions

Polidocanol (3%) 0.1ml intralesional injection per 10mm diameter lesion

Polidocanol Injection

Diona Damian

There is currently an urgent need for low cost and well tolerated intralesional agents for the management of in transit and cutaneous melanoma metastases that are unsuitable for, or resistant to, other therapies. This pilot study will determine whether intralesional injections of the sclerosant polidocanol into intransit and cutaneous melanoma lesions shows promise for efficacy, safety and ease of use that will enable this inexpensive and widely available agent to undergo further evaluation.

Many patients with metastatic melanoma have in transit and other cutaneous metastases. Untreated, these lesions become eroded, haemorrhagic and symptomatic. When systemic therapy is not warranted, has failed or is not tolerated for in transit disease, and when surgery is not feasible or appropriate, other local treatments are needed. Current options include isolated limb infusion for bulky limb disease, topical immunotherapy with contact sensitisers and imiqiuimod for superficial, nonbulky disease or radiation therapy. Intralesional (IL) agents such as Rose Bengal (PV-10, Provectus) and Talimogene laherparepvec (T-Vec, Amgen) have been used for patients with limited numbers of cutaneous metastases with reported overall response rates of 51% and 26% respectively. It is thought that these IL agents can incite regional or even systemic anti-tumour immune responses, thus providing benefit beyond the individual injected lesions. Use of PV-10, which is not an intrinsic immune modulator, was associated with regression of untreated bystander lesions in 27% of patients.

T-Vec is not currently available as a subsidised product in Australia and PV-10 is not currently accessible outside of dual-agent systemic/IL clinical trials. Intralesional injection of the antimetabolites 5-fluorouracil and methotrexate has been used successfully for the treatment of cutaneous squamous cell carcinoma, but the efficacy of these agents in melanoma is unknown. Importantly, the investigator's in transit melanoma patients usually have multiple, often very numerous lesions, making IL injection with adequate volumes of antimetabolites difficult without significant risk of systemic haematologic, hepatic and renal side effects.

Hence there is currently an urgent need for tolerable, low cost and accessible intralesional therapies for in transit and cutaneous melanoma metastases.

This study aims to evaluate the efficacy and tolerability of intralesional therapy with the sclerosant polidocanol for treatment of in transit and cutaneously metastatic melanoma unsuitable for other therapies.

Intravascularly injected sclerosants have a long history of safe and effective use in the treatment of varicose veins. Sclerosants have also been used intralesionally for the treatment of cutaneous lesions such as squamous cell carcinoma, pyogenic granulomas, Kaposi sarcoma and angiomas. They are inexpensive, readily accessible and can be easily administered in the clinic to multiple metastases. By inciting cell death within melanoma metastases in the skin, they may also incite anti-tumour immune responses in untreated bystander lesions, as is observed with IL PV-10 therapy.

Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases

Proportion of patients with a complete response (complete disappearance of treated lesions), partial response (a 25% or more reduction in size of treated lesions), stable disease (a 0 to 24% reduction in size of treated lesions) or disease progression (any increase in size of treated lesions)

Treatment related adverse events using the CTCAE version 4 terms and grading.

Proportion of patients with a complete response (complete disappearance of untreated lesions), partial response (a 25% or more reduction in size of untreated lesions), stable disease (a 0 to 24% reduction in size of untreated lesions) or disease progression (any increase in size of untreated lesions)

The proportion (%) of tumour-infiltrating immune markers: CD4, CD8 and FoxP3 T cell markers, CD20 (B cell), CD16 and CD56 Natural Killer (NK) cell markers, Ki67 marker of proliferation, CD31 (endothelial cells) and CD68 and CD163 (macrophages) detected at baseline and 1 week after intralesional injection by immunohistochemistry. The same analysis will be undertaken in a minimuim of one untreated lesion detected at baseline and at anytime between 1 and 8 weeks. Change in the proportion (%) of immune markers will be ,made within each lesion and between each lesion.

The proportion of residual non-necrotic melanoma cells detected histolologcally in treated and untreated lesions one week after intralesional injection.

Melanoma Institute Australia

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Nodule

Cysts

Endocrine System Diseases

Pathological Conditions, Anatomical

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Anti-Infective Agents, Local

Polidocanol is injected in the thyroid cyst under ultrasound guidance.

Alcohol is injected in the thyroid cyst under ultrasound guidance.

Polidocanol is injected under complete aseptic conditions. Before the treatment the diameter and volume of each nodule is calculated. To prevent serious hemorrhage, vessels located along the approach route will be carefully evaluated by using Doppler US.

Alcohol is injected under complete aseptic conditions. Before the treatment the diameter and volume of each nodule is calculated. To prevent serious hemorrhage, vessels located along the approach route will be carefully evaluated by using Doppler US.

Alcohol

Amna Ahmed

Hany Seif

This study aims to compare the efficacy and safety of ultrasound-guided percutaneous ethanol injection and percutaneous polidocanol injection for the treatment of benign cystic and predominantly cystic thyroid nodules.

Thyroid nodules are characterized by excessive structural growth, functional transformation, and/or cystic degeneration of one or several areas within the gland. According to various studies, 15-30% of thyroid nodules are cystic or predominantly cystic. Around 5% of patients with thyroid nodules may experience compressive symptoms or cosmetic concerns, and treatment may be required in these cases.

Simple aspiration is generally the initial management for the purpose of diagnosis and cyst volume reduction. However, the recurrence rate has been reported to be high (40% to 59%), depending on the number of aspirations and extent of fluid evacuation. After simple fine-needle aspiration, most cystic lesions (around 80%) refill and enlarge over time.

Surgery is a long-established therapeutic option for benign thyroid nodules. However, the cost of thyroid surgery, risk of temporary or permanent complications, and impact on quality of life remain relevant concerns.

Ultrasound-guided percutaneous ethanol injection (PEI) The mechanism of ethanol sclerotherapy is that ethanol induces cellular dehydration and protein denaturation, which are followed by coagulation necrosis, reactive fibrosis, and small-vessel thrombosis.

As regard (PEI)Pain is the most common side effect, other mild side effects or complications occurred in small numbers of patients like: Facial flushing, Mild dizziness, Intracystic haemorrhage, drunken sense, Perithyroidal leakage. There are other side effects, including transient vocal cord palsy, respiratory distress requiring emergency surgical treatment, and venous thrombosis, in sporadic cases.

Percutaneous Polidocanol sclerotherapy (PPI) may be a potential alternative to ethanol for the treatment of benign cystic and predominantly cystic thyroid nodules.Polidocanol is a liquid detergent sclerosant developed in 1936 as a topical and local anaesthetic consisting of 95% hydroxy poly ethoxydodecane and 5% ethyl alcohol. It has been used as a treatment for hemorrhoidal disease, venous malformations, symptomatic hepatic cysts, renal cysts, gastric varices, and digital mucous cysts.

The mechanism of treating cyst is probably destroying endothelial cells of capsular wall which causes aseptic inflammation; thus endothelial tissue atrophies and cyst cavity adhere and occlude.

The side effects are mild including mild localized pain and mild or moderate fever after PPI. So, PPI could be a safe and effective alternative to treat benign cystic or predominant cystic thyroid nodules.

Based on determining the main outcome variable, the estimated minimum required sample size is 30 patients (15 patient in each group).

The sample was calculated using G\*power software 3.1.9.2., based on the following assumptions: Main outcome variable is the difference between mean value of:

Group (A): 15 patients will be treated by Ultrasound-Guided Percutaneous Polidocanol Injection Group (B): 15 patients will be treated by Ultrasound-Guided percutaneous ethanol injection

Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst

Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous Ultrasound Guided Treatment of Benign Thyroid Cyst

Size of the thyroid cyst is measured by ultrasound after 3 months of sclerosing agent injection

Assiut University

Doctor

Ganglion Cysts

Synovial Cyst

Mucinoses

Connective Tissue Diseases

polidocanol

infra-red coagulation

cryotherapy

Stephen A Holme, MBChB

Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.

An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst

An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts

Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?

In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in the percentage of participants with cyst resolution at 12 and 52 weeks post initial treatment

In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring

In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure pain/discomfort

In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction

NHS Lothian

Foundation for Skin Research

University of Edinburgh

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Pain

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Gastrointestinal Agents

Deoxycholic Acid

Injection into the cutaneous Neurofibromas lesion.

Pulse laser at a wavelength of 1064nm to the cutaneous Neurofibromas lesion.

1064nm Nd:YAG laser

Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion

755nm Alexandrite Laser

Devon Gunter

Gina-Fae Fillingham

Fernanda Sakamoto, MD, PhD

Richard R Anderson, MD

Patricia Richey, MD

This study will evaluate the effectiveness of skin cooling in increasing tolerability of four treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 980nm laser, a 755nm laser, radio-frequency injection, and a Kybella injection. Each patient will have a treatment and a control site..

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Measured by photography completed by member at medical team

Measured via clinically completed 2D and 3D photography

Device based treatment will be considered tolerable if \<40% of participants treated have a \>grade 2 adverse event (AE). A grade 2 AE is defined as an event that requires treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases	NCT03754140	Melanoma In-Transit Meta...	Polidocanol Inj...	18 Years -	Melanoma Institute Australia
Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst	NCT05798936	Benign Thyroid ... Thyroid Lump Thyroid Cyst	Polidocanol Alcohol	10 Years - 75 Years	Assiut University
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst	NCT02154789	Ganglion Cysts	polidocanol infra-red coagu... cryotherapy	18 Years -	University of Edinburgh
Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst	NCT05798936	Benign Thyroid ... Thyroid Lump Thyroid Cyst	Polidocanol Alcohol	10 Years - 75 Years	Assiut University
Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas	NCT06132165	Neurofibromatos...	Deoxycholic Aci... Polidocanol 1064nm Nd:YAG l... 755nm Alexandri...	18 Years - 80 Years	Massachusetts General Hospital
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst	NCT02154789	Ganglion Cysts	polidocanol infra-red coagu... cryotherapy	18 Years -	University of Edinburgh
Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases	NCT03754140	Melanoma In-Transit Meta...	Polidocanol Inj...	18 Years -	Melanoma Institute Australia

Spots Global Cancer Trial Database for polidocanol

Every month we try and update this database with for polidocanol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for polidocanol

Every month we try and update this database with for polidocanol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for polidocanol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.